Merck Wins Lawsuit Brought By Fosamax Patient

NEW YORK -- Merck & Co. said Monday it won a third lawsuit
brought by a patient who said the company’s former
blockbuster osteoporosis drug Fosamax caused dental and jaw
problems.

The company faces more than a thousand lawsuits brought by
patients who say they developed jaw and dental problems including
osteonecrosis of the jaw -- or rotting of the jawbone -- after
using Fosamax. Merck has now won three of the four lawsuits that
have gone to trial.

On Monday the company said a jury in the Superior Court for
Atlantic County, N.J., found that Fosamax did not cause the
patient’s dental and jaw problems. The patient used Fosamax
from 1999 to 2006, and suffered jaw problems after having a tooth
removed in December 2005. Merck said the woman’s history of
dental problems and use of steroid medications contributed to those
problems.

In the fourth Fosamax case that has gone to trial, a jury
awarded the plaintiff $8 million. That amount was later reduced to
$1.5 million, and Merck is appealing the verdict. The Whitehouse
Station, N.J., company said about 1,180 lawsuit related to Fosamax
have been filed, including about 1,560 plaintiff groups. The three
other cases are being held in federal court; Monday’s verdict
comes from a state level proceeding.

Separately, the Kaiser Permanente Center for Health Research
said Monday a study published in a medical journal links Fosamax to
osteonecrosis of the jaw -- but says the risk is "extremely low,"
occurring in less than a tenth of 1 percent of patients.
Osteonecrosis of the jaw occurs when blood flow to the bone is
reduced for an extended period of time, generally more than six to
eight weeks.

A study published in the Journal of Dental Research found oral
bisphosphonate drugs like Fosamax can cause osteonecrosis of the
jaw. The results were based on a review of records of 572,606
patients. The review was conducted by Kaiser and the HealthPartners
Research Foundation. It was funded by grants from the National
Institutes of Health.

The lead author of the study said previous research indicated
that about 1 percent of patients who take oral bisphosphonates
develop osteonecrosis of the jaw. The study found 23 cases of the
condition, with the majority found in patients who had other risk
factors, like cancer, osteoporosis, or radiation treatment
targeting the head and neck. A total of 21,164 patients were
prescribed oral bisphosphonates, and six of them developed
osteonecrosis of the jaw. Patients who took oral bisphosphonates
were more likely to develop the condition than patients who did
not.

Merck has said that there were no cases of osteonecrosis of the
jaw in any clinical trials of Fosamax.

Kaiser Permanente said about 4.7 million Americans are taking
oral bisphosphonate drugs. Generic versions of Fosamax, or
alendronate, reached the market in February 2008. Before that, the
drug was a multi-billion-seller for Merck.